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The Effect of Adding Non-saturated Fatty Acid Omega 3 and Placebo on anti-Depressant Drugs among Patients with Depression Disorder

Protocol summary

Study aim
The Effect of Adding Non-saturated Fatty Acid Omega 3 and Placebo on anti-Depressant Drugs among Patients with Depression Disorder
Design
randomised, blinded, controlled clinical trial with a parallel group
Settings and conduct
Patients were first evaluated by the Beck Test . Finally, the participants with a score of over 13 were selected. The patients were divided randomly into two groups of 30,The two groups were the same with respect to antidepressant. In the two groups, in addition to specific serotonin reuptake inhibitors, omega- 3s was given at a daily dose of 300-600 mg. In the control group, in addition to specific inhibitors of serotonin reuptake, a placebo was prescribed. The two groups were analyzed in weeks 0, 2 , 4 , 6 and 8 so that the researchers could assess the level of depression and functional testing based on the Beck Test.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age ranging from 18- 65years, major depressive disorder based on DSM-IV Index confirmed by a psychiatrist. Exclusion criteria: incorporated bipolar disorder and other psychiatric disorders, drug or alcohol consumption during the research, dependence or history of drug or alcohol in 6 recent months, history of allergy to serotonin reuptake inhibitors or omega- 3fatty acids , history of seizure, pregnancy, active suicidal thoughts and homicide, chronic physical disease , use of anticoagulants and medications that interfere with omega- 3 intake
Intervention groups
one group was given selective serotonin reuptake inhibitors plus omega-3 fatty acids and other group received selective serotonin reuptake inhibitors in addition to placebo.
Main outcome variables
Severity of depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201125049487N1
Registration date: 2020-12-22, 1399/10/02
Registration timing: retrospective

Last update: 2020-12-22, 1399/10/02
Update count: 0
Registration date
2020-12-22, 1399/10/02
Registrant information
Name
Sara Behbahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3416 2202
Email address
farahmand.karen@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-08-20, 1395/05/30
Actual recruitment start date
2016-05-21, 1395/03/01
Actual recruitment end date
2016-08-20, 1395/05/30
Trial completion date
2016-10-21, 1395/07/30
Scientific title
The Effect of Adding Non-saturated Fatty Acid Omega 3 and Placebo on anti-Depressant Drugs among Patients with Depression Disorder
Public title
Effect of Omega3 in depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with major depressive disorder who had been to the psychiatric clinic of Golestan. Age witbeen 18-65 years
Exclusion criteria:
Bipolar disorder and other psychiatric disorders Drug or alcohol consumption during the research, dependence or history of drug or alcohol in 6 recent months, History of allergy to serotonin reuptake inhibitors or omega- 3fatty acids History of seizure Pregnancy Active suicidal thoughts and homicide Use of anticoagulants and medications that interfere with omega- 3 intake (such as anti-platelet drugs such as aspirin and enoxaparin and heparin and warfarin) chronic physical disease ( blood pressure, diabetes, heart disease, liver and kidney disease )
Age
From 18 days old to 65 days old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was according to permutation block with size of 4 with toss a coin divided randomly into two equal groups of people.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blindness was according to the fact that which the patients did not know what type of drug they received. The capsule of omega- 3 fatty acids and placebo were exactly in the same shape, color, smell and taste.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of ahwaz University of Medical Science
Street address
Golestan Blvd, ahwaz University of Medical Science
City
Ahwaz
Province
Khouzestan
Postal code
٦١٣٦٨٣٥٦٨٥
Approval date
2016-07-09, 1395/04/19
Ethics committee reference number
IR.AJUMS.REC.1395.234

Health conditions studied

1

Description of health condition studied
Major depressive disorder
ICD-10 code
F33.2
ICD-10 code description
Major depressive disorder, recurrent severe without psychotic features

Primary outcomes

1

Description
Depression values in beck test
Timepoint
From the start of treatment and week 2,4,6,8
Method of measurement
Beck test

Secondary outcomes

1

Description
Dose of SSRI
Timepoint
At the beginning of treatment and week 2,4,6,8 after tratment started
Method of measurement
Evaluation of drug used based of patient file

Intervention groups

1

Description
Control group: control group with 30 patients that received special serotonin reuptake inhibitors ( fluvoxine20-80 mg or citalopram 20-40, or sertraline with congestion 50-200 mg ) in addition to a placebo(.Empty jelly capsul that made in the pharmacy school of jundishapur university) this group was tested at weeks 0, 2, 4, 6 and 8 in order to evaluate depression and functional status through Beck Test.
Category
Placebo

2

Description
One group with 30 patients which was received special serotonin reuptake inhibitors ( fluvoxine20-80 mg or citalopram 20-40, or sertraline with congestion 50-200 mg ) in addition to omega- 3 fatty acid 300-600mg per day in the form of peal omega3 zahravi company for 8 weeks, were tested at weeks 0, 2, 4, 6 and 8 in order to evaluate depression and functional status through Beck Test.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Maasome nazari nasab
Street address
Golestan Blvd, golestan hospital
City
Ahwaz
Province
Khouzestan
Postal code
6136835685
Phone
+98 61 3375 4123
Email
masomenazari@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sara behbahani
Street address
Number 23, khordad 2 street, naft down city
City
Ahwaz
Province
Khouzestan
Postal code
6136835577
Phone
+98 61 3416 2204
Email
Farahmand.karen@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Individual
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maasome nazari nasab
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Golestan Blvd, Golestan hospital
City
Ahwaz
Province
Khouzestan
Postal code
6136835685
Phone
+98 61 3375 4123
Email
masomenazari@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maasome nazari nasab
Position
Proffesor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Golestan Blvd, Golestan hospital
City
Ahwaz
Province
Khouzestan
Postal code
6136835685
Phone
+98 61 3375 4123
Email
masomenazari@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sara behbahani
Position
Assistant
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Number 23, khordad 2 street, naft Blvd
City
Ahwaz
Province
Khouzestan
Postal code
6136835685
Phone
+98 61 3416 2204
Email
Farahmand.karen@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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